MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D160903

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 09/12/2023

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 05-oct-2023.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure involving an octaray mapping catheter and experienced cardiac arrest.While mapping with the octaray mapping catheter, when going anterior, the patient's blood pressure dropped and the patient experienced bradycardia.They confirmed that the heart slowed and then stopped.It was discovered and confirmed on the intracardiac ultrasound and on intracardiac echocardiography (ice).They checked for a pericardial effusion and found none.The medical intervention was chest compressions and put the octaray catheter into the left ventricle to begin pacing.They re-checked the patient for an effusion and confirmed that there were none.They cardioverted the patient and the patient stabilized.The procedure was aborted.They pulled everything out of the left atrium, kept the decanav catheter in for a bit to monitor the patient, excavated the patient, and sent them to the intensive care unit (icu) to get a cat scan.Patient stayed overnight, and the atrial fibrillation ablation procedure was completed the next day with no complications and full recovery.The physician was unsure as to what caused the adverse event, but their hypothesis was that a combination of issues occurred at once.The physician believed that the cooling esophageal catheter might have gotten too cold and the event was noticed when the respiration was changed by the anesthesiologist during the procedure.Physician's opinion is that no malfunction occurred with biosense webster inc.Product and the event is not related to patient's condition.In addition, they also reported that in the procedure, they were unable to cross the septum and when the device was taken out, it looked as though the tip was bent and squished back on itself.To troubleshoot, the vizigo sheath was replaced and the issue was resolved.The adverse event was assessed as mdr reportable.The issue of the tip bent and squished back on itself was assessed as non mdr reportable.

Manufacturer Narrative

Confirmation received on 10-oct-2023 clarifying that the non mdr reportable issue of the device which looked as though the tip was bent and squished back on itself was the concomitant product of the vizigo sheath.The device evaluation was completed on 12-oct-2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure involving an octaray mapping catheter and experienced cardiac arrest.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: OCTARAY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17886867
• MDR Text Key: 325117932
• Report Number: 2029046-2023-02249
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: 10846835021127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D160903
• Device Lot Number: 31071258L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; 8.5F SHEATH WITH CURVE VIZ MDC; SOUNDSTAR ECO GE 10F CATHETER; THMCL SMTCH SF BID, TC, D-F; UNK SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male